Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02795143|
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : December 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Toxic Epidermal Necrolysis||Drug: Isotretinoin Other: Placebo||Not Applicable|
Toxic epidermal necrolysis (TEN) is a potentially life-threatening skin disorder characterized by widespread redness, blistering and peeling of skin.
Currently, supportive care in the standard treatment for patients with TEN. Isotretinoin, an FDA-approved medication commonly used for treating severe acne induces differentiation of certain inflammatory cells and thus may potentially be helpful in treating patients with TEN.
This is a randomized, placebo-controlled, double-blind, pilot study comparing the efficacy and safety of isotretinoin versus placebo in treating subjects with toxic epidermal necrolysis (TEN).
Approximately 40 subjects who satisfy all inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either isotretinoin or placebo which they will take for up to 14 days. The end of the study is defined as the time the subject is discharged from the hospital. Participants will primarily be assessed for percent body surface affected (BSA) and number of days of hospitalization.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Isotretinoin will be given at the following dosage:
Dosing will be as listed on the table below.
Weight in Kg Total Daily Dose 40-49 Kg 40mg 50-89 Kg 80mg 90-150 Kg 120mg
Placebo Comparator: Placebo
Subjects will be given placebo capsules twice a day.
- Number of days of hospitalization [ Time Frame: up to 14 days ]Number of days patient will be hospitalized.
- Percent of body surface affected (BSA) [ Time Frame: up to 14 days ]Maximum body surface affected with TEN.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795143
|Contact: Arturo Saavedra, MD, PhDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Arturo Saavedra, MD, MBA 617-726-5066 firstname.lastname@example.org|
|Principal Investigator: Arturo Saavedra, MD, MBA|
|Principal Investigator:||Arturo Saavedra, MD, PhD||Massachusetts General Hospital|